• Regulations for SCRO Clinical Trials and ClinicalTrials.gov (pdf)
• Additional Element of Consent: ClinicalTrials.gov (pdf) • Additional Element of Consent: ClinicalTrials.gov
• (A) Determination of Human Subject Research; (B) Exempt Categories (pdf)
• [SCRO] Updates to Stem Cell Research Oversight (pdf)
• Guidance on Unanticipated Problems (UPs) and Adverse Events (AEs) (Medical, pdf) • Guidance on Unanticipated Problems (UPs) and Adverse Events (AEs) (Non-Medical, pdf)
• CIRM Disease Team MPP Grants (Presentation to IRB 3/SCRO, pdf)
• General Requirements for Informed Consent (Medical, pdf) • General Requirements for Informed Consent (Non-Medical, pdf)
• SCRO Consent Requirements (pdf)
• Stem Cell Terminology (pdf)
• Short Form Consent Process (pdf)
• Sponsor-Investigator Research [SIR] and Investigational New Drugs [INDs] (pdf)
• Criteria for IRB Approval of Research (Medical, pdf) • Criteria for IRB Approval of Research (Non-Medical, pdf)
• A Guide for the Combined IRB/SCRO (pdf)
• IRB Member Orientation (pdf)
• Resources Supporting the HRPP (pdf)
• Additional Protections for Pregnant Women, Fetuses and Neonates (pdf)
• Survey Research in Public Schools (PPRA Regulation, pdf)